The Verigene® Staphylococcus Blood Culture (BC-S) Nucleic Acid Test performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacterial species Staphylococcus aureus ("SA") and Staphylococcus epidermidis ("SE") which may cause bloodstream infection (BSI). In addition, the BC-S test detects the mecA resistance marker inferring mecA-mediated methicillin/oxacillin resistance. In mixed growth, the BC-S Test does not specifically attribute mecA-mediated methicillin/oxacillin resistance to either SA or SE.

The BC-S test is performed directly on positive blood culture using BACTEC™ Plus Aerobic/F and BacT/ALERT FA FAN® Aerobic blood culture bottles, which contain gram-positive cocci in clusters (GPCCL) observed on Gram stain. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation of mixed growth, association of the mecA gene to an organism, or for epidemiological typing.

The BC-S test is indicated for use in conjunction with other clinical and laboratory findings, such as culture, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections.

Device Description

The Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S) is a molecular assay which relies on detection of specific nucleic acid targets in a microarray format. For each of the bacterial nucleic acid sequences detected by the BC-S test, Capture and Mediator oligonucleotides are utilized for gold nanoparticle probe-based endpoint detection. The Capture oligonucleotides bind to a specific portion of the nucleic acid target and are themselves bound onto a substrate in the microarray. The Mediator oligonucleotides bind to a different portion of the same nucleic acid target and allow binding of a gold nanoparticle probe to a portion complementary to a gold nanoparticle probe. Specific silver enhancement of the bound gold nanoparticle probes at the capture sites results in gold-silver aggregates that scatter light with high efficiency.

The BC-S test is performed on the Verigene System, a 'sample-to-result', fully automated, bench-top molecular diagnostics workstation. The Verigene System consists of two components: the Verigene Reader and the Verigene Processor SP. The BC-S test utilizes single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested. For the BC-S test, the Verigene System allows automated nucleic acid extraction from gram-positive bacteria-containing blood culture specimens and target detection of bacteria-specific DNA.

The Reader is the Verigene System's user interface, which serves as the central control unit for all aspects of test processing and results generation. The Reader's graphical user interface guides the user through test processing and test results using a barcode scanner.

The user inserts the Test Cartridge into the Verigene Processor SP, which executes the test procedure, automating the steps of ( ) Sample Preparation - Cell lysis and magnetic bead-based bacterial DNA isolation from blood culture samples and (2) Verigene Hybridization Test - Detection and identification of bacterial-specific DNA in a microarray format by using gold nanoparticle probe-based technology.

After test processing is complete, to obtain the test results the user removes the Test Cartridge from the Processor SP, removes the reagent pack from the substrate holder, and inserts the substrate holder into the Reader for analysis. Light scatter from the capture spots is imaged by the Reader and intensities from the microarray spots are used to make decisions regarding the presence (Detected) or absence (Not Detected) of a bacterial nucleic acid sequence/analyte.

AI/ML Overview

This document describes the regulatory submission for the Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S) and its performance characteristics.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the clinical performance in a pass/fail sense with numerical targets. However, the "Method Comparison Study" results can be interpreted as the device's reported performance against a reference standard. The goal implicitly is high agreement with the reference methods.

Analyte	Performance Metric	Reported Device Performance
S. aureus	Sensitivity	100% (97.1%-100% CI)
S. aureus	Specificity	100% (98.2%-100% CI)
S. epidermidis	Sensitivity	97.0% (91.2%-99.4% CI)
S. epidermidis	Specificity	99.6% (97.6%-99.9% CI)
mecA gene	Sensitivity	98.6% (94.6%-99.8% CI)
mecA gene	Specificity	98.8% (93.4%-99.9% CI)

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: 330 culture-positive, gram-positive (GPCCL) blood culture specimens from patients.
Data Provenance:
- Country of Origin: Not explicitly stated, but the study was conducted at "five external clinical sites," implying clinical settings within a country, likely the US given the FDA submission.
- Retrospective or Prospective: Prospective, as subjects were "individuals receiving routine care requiring blood culture testing" and "specimens from these patients were identified for BC-S testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not explicitly stated.
Qualifications of experts: The ground truth was established using "reference method results obtained from the standard biochemical bacterial detection and susceptibility techniques utilized in routine clinical practice." This implies standard microbiology laboratory personnel and practices, rather than a panel of individual experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No explicit adjudication method is mentioned for the test set. The comparison was made against "reference method results obtained from the standard biochemical bacterial detection and susceptibility techniques utilized in routine clinical practice," suggesting a direct comparison rather than a consensus process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic test for bacterial identification and resistance markers, not an imaging analysis tool that relies on human reader interpretation of images. The study focuses on the device's performance against standard microbiological methods.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the performance data presented (analytical and clinical) represents the standalone performance of the Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S) and the Verigene® System. The system is described as a "sample-to-result, fully automated, bench-top molecular diagnostics workstation," implying minimal human intervention beyond setting up the test. The "Method Comparison Study" directly compares the device's output to standard laboratory results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used was reference method results obtained from standard biochemical bacterial detection and susceptibility techniques utilized in routine clinical practice. This essentially means the results from conventional microbiology tests (e.g., culture, biochemical identification, antimicrobial susceptibility testing) performed in clinical laboratories.

8. The sample size for the training set:

The document does not explicitly state the sample size for a "training set." The performance data section focuses on "Analytical Testing" and "Clinical Testing" (Method Comparison Study, Reproducibility Study). In vitro diagnostic tests like this typically undergo extensive analytical validation (LOD, inclusivity, exclusivity, etc.) using characterized strains and then clinical validation with patient samples. The term "training set" is more common in machine learning contexts, which this device does not appear to primarily utilize in the same way. The strains used for "Analytical Reactivity (Inclusivity)" and "Analytical Specificity (Exclusivity)" could be considered part of developmental data but aren't explicitly called a training set.

9. How the ground truth for the training set was established:

As a "training set" is not explicitly mentioned in the context of machine learning model training, the method for establishing its ground truth is not provided. However, the ground truth for the analytical validation (inclusivity/exclusivity) would have been established by standard microbiological characterization of the bacterial strains used (e.g., genetic sequencing, biochemical tests, culture).

Summary

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5. 510(K) Summary

The Summary for this 510(k) submission is submitted in accordance with the requirements of SMDA 1900 and CFR 807.92. Attachment A contains the 510(k) screening checklist and Attachment B contains the complete 510(k) Summary.

510(k) Number:

Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S) K112424

Summary Preparation Date:

August 19, 2011 (Revised December 13, 2011)

Submitted by:

Nanosphere, Inc. 4088 Commercial Avenue Northbrook, IL 60062 Phone: 847-400-9000 Fax: 847-400-9199

Contact:

Mark Del Vecchio VP, Regulatory Affairs and Quality Assurance

Proprietary Names:

For the instrument:

Verigene® System

For the assay:

Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S)

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Common Names:

For the instrument:

Bench-top molecular diagnostics workstation

For the assay:

Rapid gram-positive blood culture assay Staphylococcus aureus-Staphylococcus epidermidis blood culture assay Methicillin-resistant Staphylococcus aureus (MRSA) blood culture assay Methicillin-resistant Staphylococcus epidermidis (MRSE) blood culture assay

Regulatory Information:

Regulation section:

866.1640 Antimicrobial susceptibility powder

Classification:

Class II

Panel:

Microbiology (83)

Product Code(s):

NQX System, nucleic acid amplification test, DNA, methicillin-resistant Staphylococcus aureus, direct specimen

Other:

Instrumentation for clinical multiplex test systems NSU

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Predicate Devices:

Xpert MRSA/SA Blood Culture Assay (Cepheid)

S. aureus/CNS PNA FISH Culture Identification Kit (AdvanDx)

Phoenix Gram Positive (GP) Panel - Phoenix Automated Microbiology System (Cefoxitin) (Becton-Dickinson)

Verigene RVNAT5P Test (Nanosphere)

Indications for Use:

Technological Characteristics:

CONFIDENTIAL AND PROPRIETARY Nanosphere, Inc.

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Performance Data - Analytical Testing

Analytical Sensitivity / Limit of Detection (LOD)

Analytical sensitivity (LODs) for detection of 13 strains tested ranged from 1.9 x 108 to 7.5 x 106 CFU/mL.

Analytical Reactivity (Inclusivity)

Demonstrated reactivity to strains included 99 MRSA strains (including 65 representative NARSA strains), 18 methicillin-sensitive Staphylococcus aureus (SA), eight (8) borderline oxacillin-resistant Staphylococcus aureus or BORSA strains, six (6) methicillin-resistant Staphylococcus epidermidis (MRSE), and seven (7) methicillinsensitive Staphylococcus epidermidis (SE).

Analytical Specificity (Exclusivity)

No cross-reactivity observed for any of the strains tested, which included 157 bacterial (115 gram-positive and 40 gram-negative, 1 acid-fast positive and 1 mollicute) and 6 yeast strains.

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Interfering Substances

No inhibitory effects observed from interfering substances including hemoglobin, triglycerides, bilirubin, gamma-globulin, and SPS, introduced directly into blood and then cultured in the blood culture bottle. Multiple types of blood culture bottles were also tested.

Fresh vs. Frozen Samples

Test results for representative strains of MRSA/SA and MRSE/SE were unaffected by exposure to up to two freeze/thaw cycles.

Competitive Inhibition

Competitive inhibition representing mixed bacteremia with SA and SE was evaluated by testing SA/MRSA samples at a high titer in the presence of SE/MRSE at a low titer (at LOD) and vice versa. No evidence of competitive inhibition was observed.

Carry-over / Cross-contamination

No evidence of carryover and/or cross-contamination from the high positive samples, or any other internal or external sources, was observed during either the sample extraction and hybridization procedural steps, when alternately running high positive samples followed by true negative samples.

Performance Data - Clinical Testing

Precision and Reproducibility Studies

The Reproducibility Study was conducted at three external sites and the Precision Study took place internally at Nanosphere, Inc. The Precision and Reproducibility Study Panel comprised of twelve (12) specimens, consisting of pure isolates grown in blood culture bottles until bottle positivity and bottle positivity plus an additional 8 hours. The specimens included 2 levels of 2 different MRSA strains, 2 levels of a MRSE strain. 2 negative controls (1 media only and 1 bacterial), 2 levels of an SA strain, and 2 levels of an SE strain.

Each specimen was tested in duplicate twice daily by two operators for twelve days (precision) and five days (reproducibility). The study demonstrated excellent reproducibility across multiple reagent lots, days, operators, runs, instruments and replicates.

Precision	Reproducibility
NS	Site 1	Site 2	Site 3	All Sites
100 %(576/576)99.4 % - 100 %	100 %(240/240)98.5 % - 100 %	100 %(240/240)98.5 % - 100 %	100 %(240/240)98.5 % - 100 %	100 %(1296 / 1296)99.7 % - 100 %

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Method Comparison

The Method Comparison Study was conducted at five external clinical sites. Subjects included individuals receiving routine care requiring blood culture testing. Three-hundred and thirty (330) culture-positive, gram-positive (GPCCL) blood culture specimens from these patients were identified for BC-S testing. BC-S test results were compared with reference method results obtained from the standard biochemical bacterial detection and susceptibility techniques utilized in routine clinical practice.

S. aureus (n=330)	S. epidermidis (n=330)
Sensitivity =100% (97.1%-100%)	Sensitivity = 97.0% (91.2%-99.4%)
Specificity=100% (98.2%-100%).	Specificity= 99.6% (97.6%-99.9%)
mecA (n=221)
Sensitivity =98.6% (94.6%-99.8%)

Substantial Equivalence

Specificity= 98.8% (93.4%-99.9%)

The Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S) is as safe and effective as the AdvanDx S. aureus/CNS PNA FISH Culture Identification Kit, Cepheid Xpert MRSA/SA Blood Culture Assay, BD Phoenix Gram Positive (GP) Panel - Phoenix Automated Microbiology System (Cefoxitin) and Nanosphere Verigene RVNAT sp. The BC-S has similar intended use and indications, technological characteristics, performance characteristics and principles of operation as its predicate devices. The minor differences between the BC-S and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the BC-S is as safe and effective as predicate devices. Thus, the BC-S is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.

10903 New Hampshire Avenue Silver Spring, MD 20993

Nanosphere, Inc. c/o Mark A. Del Vecchio Vice President, Regulatory Affairs 4088 Commercial Avenue Northbrook, IL 60062

DEC 1 6 2011

Re: K112424

Trade/Device Name: Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S) on the Verigene® System Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: NQX, NSU Dated: December 13, 2011 Received: December 15, 2011

Dear Mr. Del Vecchio:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nallartagna

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

510(k) Number (if known): K112424

Device Name: Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S) on the Verigene® System

The BC-S test is performed directly on positive blood culture using BACTEC "10 Plus Aerobic/F and BacT/ALERT FA FAN® Aerobic blood culture bottles, which contain gram-positive cocci in clusters (GPCCL) observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation of mixed growth, association of the mecA gene to an organism, or for epidemiological typing.

Prescription Use (Part 21 CFR 801 Subpart D)

and/or

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie te Poole

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Office of In Vitro Diagnostic Device Evaluation and Safety

FIG(k) K112424

Z:\REGULATORY\Submissions\B BC S Test 510(k) 08192011

CONFIDENTIAL AND PROPRIETARY Nanosphere, Inc.

Page 25 of 168

ATTACHMENT 3 Page 1 of 1

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).